DRUG AND THERAPY BULLETIN

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1 H.P. STATE COUNCIL DRUG AND THERAPY BULLETIN Issue: 10 Volume: 2 Jul 2018 Contents Editorial Drug Updates Pharma News Pharma Jobs Pharma Expo India Which kind of queries can be asked from Drug Information Center? Toll Free DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

DRUG AND THERAPY BULLETIN EDITORIAL Patron Mr. Gopal Krishan Sharma and Dr. Ran Singh Editor-in-chief Dr. Kamlesh Naik and Dr. M.S. Ashawat Co-Editors Dr. Vinay Pandit and Mr.

2 DRUG AND THERAPY BULLETIN EDITORIAL Patron Mr. Gopal Krishan Sharma and Dr. Ran Singh Editor-in-chief Dr. Kamlesh Naik and Dr. M.S. Ashawat Co-Editors Dr. Vinay Pandit and Mr. Ankush Sharma Advisory Board Dr. Navneet Marwah, Mr. Sanjeev Pandit, Dr. Manoj Kumar, Dr. Ranjit Singh, Prof. CPS Verma, Dr. Poonam Sandhu, Dr. Rajender Guleria, Mr. Arvind Kumar, Mr. Bihari Lal Gupta, Mr, Hemant Sharma, Mr. Rakesh Chandel, Mr. Praveen Upadhya, Mr. Kamashwar Chauhan, Mr. Lokesh Kumar, Mr. Vishal Kumar, Mr. Y.S.Chandel, Mr. Birbal Sharma, Mr. Manoj Kumar, Mr. Yogesh Verma, Mr. Surender Nadda, Dr. Parshuram Content Drug Updates Pharma News Pharma Jobs Others

DRUG UPDATES Zemdri for complicated UTI On June 26, 2018, the US FDA approved Zemdri (plazomicin) IV injection indicated for the treatment of complicated UTI, including pyelonephritis, caused by

3 DRUG UPDATES Zemdri for complicated UTI On June 26, 2018, the US FDA approved Zemdri (plazomicin) IV injection indicated for the treatment of complicated UTI, including pyelonephritis, caused by certain Enterobacteriaceae in adult patients who have limited or no alternative treatment options. Zemdri, the first once-daily aminoglycoside approved for this indication, demonstrated similar efficacy to meropenem for achieving composite cure (resolution or improvement of clinical symptoms and microbiological eradication) in a noninferiority clinical trial of patients with complicated UTI. accessdata.fda.gov/drugsatfda_docs/label/2018/ Orig1s000lbl.pdf. Marijuana derived Epidiolex approved On June 25, 2018, the US FDA approved Epidiolex(R) (cannabidiol) oral solution indicated for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age or older. Epidiolex, which is the first marijuana-derived drug to gain FDA approval, demonstrated a greater reduction in seizure frequency when administered along with other drugs compared with placebo in 3 clinical trials. accessdata.fda.gov/drugsatfda_docs/label/2018/ lbl.pdf. Nocdurna sublingual tablets approved On June 21, 2018, the US FDA approved Nocdurna(R) (desmopressin acetate) sublingual tablets indicated to treat nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void. Nocdurna, which is the first sublingual desmopressin product for this indication, has gender-specific dosing and carries a boxed warning for hyponatremia. accessdata.fda.gov/drugsatfda_docs/label/2018/ s000lbl.pdf. Keytruda, Tecentric: urothelial cancer restricted use On June 20, 2018, the US FDA issued an alert that Keytruda(R) (pembrolizumab) IV injection and Tecentriq(R) (atezolizumab) IV injection use is being restricted for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing therapy. This restricted use is in response to a May 18, 2018 FDA alert. Based on an early review of 2 ongoing clinical trials, the Data Monitoring Committees found that patients in the monotherapy arms with protein programmed death ligand 1 (PD-L1) low status had decreased survival compared with those who received cisplatin- or carboplatin-based chemotherapy. The prescribing information can be found at s043lbl.pdf and fda.gov/drugsatfda_docs/label/2018/761034s010lbl. pdf. Moxidectin for river blindness On June 13, 2018, the US FDA approved moxidectin oral tablets for the treatment of onchocerciasis (river blindness) due to Onchocerca volvulus in patients 12 years of age or older. Moxidectin, which received a priority review designation from the FDA, demonstrated 3

4 DRUG AND THERAPY BULLETIN a significantly greater suppression of microfilariae in the skin compared with the current standard of care in 2 clinical trials. accessdata.fda.gov/drugsatfda_docs/label/2018/ lbl.pdf. Avastin plus chemo for Advanced ovarian Cancer On June , the US FDA approved Avastin(R) (bevacizumab) IV injection in combination with chemotherapy (carboplatin and paclitaxel), followed by bevacizumab as a single agent, for the treatment of women with advanced (stage III or IV) ovarian cancer following initial surgical resection. Avastin demonstrated efficacy in a clinical trial in which progression-free survival was significantly greater with bevacizumab plus chemotherapy followed by bevacizumab alone compared with bevacizumab plus chemotherapy followed by placebo alone or chemotherapy alone. accessdata.fda.gov/drugsatfda_docs/label/2018/ s323lbl.pdf. Keytruda for advanced cervical cancer On June , the US FDA approved a new indication for Keytruda(R) (pembrolizumab) IV injection to treat patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (combined positive score greater than or equal to 1) as determined by an FDA-approved test. Keytruda is the first anti-pd-1 therapy to gain FDA approval for patients with advanced cervical cancer and disease progression during or after chemotherapy. accessdata.fda.gov/drugsatfda_docs/label/2018/ s034lbl.pdf. Venclexta with Rituximab for CLL or SLL On June , the US FDA approved an expanded indication for Venclexta(R) (venetoclax) oral tablets in combination with rituximab for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least 1 prior therapy. Venclexta, which was granted priority review and breakthrough therapy designations from the FDA, demonstrated a significant improvement in progressionfree survival in patients with relapsed/refractory CLL patients compared with bendamustine in combination with rituximab in a clinical trial. accessdata.fda.gov/drugsatfda_docs/label/2018/ s004s005lbl.pdf Rituxan for Pemphigus vulgaris On June , the US FDA approved a new indication for Rituxan(R) (rituximab) IV injection for the treatment of adult patients with moderate to severe pemphigus vulgaris (PV). Rituxan, the first biologic therapy to gain FDA approval for PV, is also indicated to treat 4 autoimmune diseases: non-hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and granulomatosis with polyangiitis (Wegener granulomatosis) and microscopic polyangiitis. Prescribing information can be found at: gene.com/gene/products/information/pdf/rituxanprescribing.pdf. Alimta expands NSCLC indication On June , the US FDA approved an expanded 4

5 indication for Alimta(R) (pemetrexed) IV injection to include in combination with carboplatin and pembrolizumab for the initial treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), irrespective of PD-L1 expression status. Alimta, which was approved for this expanded indication under accelerated approval, demonstrated a significant improvement in objective response rate in combination with carboplatin and pembrolizumab versus in combination with carboplatin. Prescribing information can be found at: com/us/alimta-pi.pdf. Fulphila: First biosimilar to Neulasta On June 4, 2018, the US FDA approved Fulphila(TM) (pegfilgrastim-jmdb) indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Fulphila is the first biosimilar to Neulasta(R) (pegfilgrastim) to gain FDA approval; these two drugs are not interchangeable. accessdata.fda.gov/drugsatfda_docs/label/2018/ s000lbl.pdf. Reference: 5

6 DRUG AND THERAPY BULLETIN PHARMA NEWS FDA approves novel device for treating breathing difficulty from severe emphysema The U.S. Food and Drug Administration approved a new device, the Zephyr Endobronchial Valve (Zephyr Valve), intended to treat breathing difficulty associated with severe emphysema. Emphysema, including severe emphysema, is a type of chronic obstructive pulmonary disease (COPD) due to damage to the air sacs (alveoli) in the lungs. Lung damage from emphysema is irreversible. The damaged alveoli can cause used air to become trapped in the lungs during exhalation. This can cause the diseased parts of the lung to get larger and put pressure on the healthy part of the lung, which makes it difficult to breathe. As a result, the body may not get the oxygen it needs. Using a flexible bronchoscope, a doctor places Zephyr Valves, similar in size to pencil erasers, into the diseased areas of the lung airways during a procedure in a hospital setting. Design of the device is intended to prevent air from entering the damaged parts of the lung and allow trapped air and fluids to escape. During inhalation, the valves close, preventing air from entering the damaged part of the lung and during exhalation, the valves open, letting out trapped air, which is intended to relieve pressure. The Zephyr Valve device is contraindicated for patients with active lung infections; those who are allergic to nitinol, nickel, titanium or silicone; active smokers and those who are not able to tolerate the bronchoscopic procedure. Patients who have had major lung procedures, heart disease, large bubbles of air trapped in the lung or who have not responded to other treatments should talk with their providers to determine if the Zephyr Valve device is appropriate for them. Ref: Mobile apps for vaccination launched On the eve of Doctor's Day that falls on Sunday, Indian Academy of Pediatrics (IAP) in association with Kolkatabased startup Medewise Technology Solutions Private Limited launched mobile applications for child health management and immunization in Vadodara on Saturday. IAP had pioneered the Immunize India reminder service to increase vaccination compliance and provide better care and coverage to children all over the country. With the launch of MedEPed and Medewise Kids Pro the two mobile apps for child healthcare, we are taking child healthcare to the next level by leveraging technology, connectivity and data, said IAP president Dr Santosh Soans. Ref: CDSCO proposal to include all implantable medical devices & other high end equipment under the definition of 'drug The Central government has moved forward with its plan to bring all implantable medical devices and other critical medical equipment under the purview of Section 3 (b) (iv) of the Drugs and Cosmetics (D&C) Act 1940 to ensure quality and reliability. The list also includes CT scan equipment, MRI equipment, Defibrillators, Dialysis machine, PET equipment, X-Ray machine and Bone marrow cell separator. The step, which is expected to address concerns regarding patient safety, was backed by the Drug Technical. These devices will be defined as 'drugs' under the D&C Act for the purpose of price and quality control and regulated using the Medical Device Rules Ref: Oxytocin manufacturing ban for domestic use to come into effect from 1st July 2018 The Ministry of Health and Family Welfare has restricted 6

7 the manufacture of Oxytocin formulations for domestic use to public sector only from 1st July It has also banned the import of Oxytocin and its formulations. From 1st July 2018, no private manufacturer will be allowed to manufacture the drug for domestic use. Oxytocin is a naturally-occurring hormone that causes uterine contractions during labour and helps new mothers lactate. However, the drug is heavily misused in the dairy industry where livestock are injected with oxytocin to make them release milk at a time convenient to farmers. The hormone is also used to increase the size of vegetables such as pumpkins, watermelons, brinjals, gourds and cucumbers. Only Karnataka Antibiotics & Pharmaceuticals Ltd (KAPL), a public-sector company, would be manufacturing this drug for domestic use from that date. The Oxytocin formulations meant for domestic consumption will be supplied by the manufacturer, i.e. KAPL, to the registered hospitals and clinics in public and private sector directly. Oxytocin in any form or name will not be allowed to be sold through retail Chemist. All the registered hospitals and clinics in public and private sector in the country are advised to contact KAPL and place their orders with the company as the drug will not be available with retail chemists or any other manufacturer. Ref: CDSCO held meeting on introducing 'trace and track' mechanism for top 300 brands The Central Drugs Standard Control Organisation (CDSCO) has taken step to introduce an effective trace and track mechanism on top 300 brands, which would be included in the initiative. Under this proposal, the company will print a 14-digit unique number on each strip or bottle of the drug. It will also print a phone number where the customer can dial and enter the aforesaid unique number. A consumer can get the name and address of the manufacturer, the batch number, manufacturing and expiry date of the medicine. A consumer can easily check the genuineness and quality of a drug. However, the initiative will be implemented on a voluntary basis, according to the minutes of the DTAB meeting. Ref: Separate rack for generic medicines in retail shop The central government has ordered pharmacies to display generic drugs on separate shelves so that consumers can opt for generic medicine to expensive brand name drugs. The Drugs Technical Advisory Board (DTAB) agreed to keep a separate rack/shelf reserved solely for the storage of generic medicines in a part of the premises separated from other medicines, which shall be visible to consumers. Doctors will now be required to prescribe generic formulations of medicines, as opposed to specific brands. The Prime Minister has announced that prescription of medicines by their generic names will be mandatory. The government had launched the Jan Aushadhi Scheme in 2015 to sell generic drugs at an affordable rate at affordable prices in Jan Aushadhi Stores (JAS). There are around 3,500 Jan Aushadhi Stores across the country. Ref: Retail prices of 22 formulations revised by NPPA under DPCO, 2013 The National Pharmaceutical Pricing Authority (NPPA) has revised retail prices of 22 formulations under Drugs (Prices Control) Order, 2013 in a notification dated 12 June

8 DRUG AND THERAPY BULLETIN Name of the formulations are methylcobalamin + alpha lipoic acid + pyridoxine hydrochloride+folic acid + vitamin D3 1000IU tablet, cefixime + cloxacillin+lactic acid tablet (ZIFI LBX +200), omeprazole + domperidone capsule (OZSON DSR), clotrimazole+ beclomethasone cream (CZSON- B), clotrimazole+ beclomethasone+ neomycin cream (CZSON- NB), linezolid suspension (ZIFI TURBO KID), suspension (LIZOFLY), rosuvastatin + clopidogrel tablet (ROSUVAS CV 10), olmesartan + amlodipine + amlodipine tablet (Triolmezest CH 20), olmesartan+ amlodipine + amlodipine tablet (Triolmezest CH 40), telmisartan + amlodipine + chlorthalidone tablet (Telvas 3D CT 40/6.25), telmisartan+ amlodipine+ chlorthalidone tablet (Telvas 3D CT 80/6.25), Alpha lipoic + vitamin D3 + pyridoxine + mecobalamin + folic acid + biotin tablet (Nervijen D3 ) Omega - 3 ( Eicosapentaenoic + Docosahexaenoic) + mecobalamine + pyridoxine + folic acid + vitamin E + vitamin C + zinc sulphate+sodium selenite capsule (Omegaful), thiamine mononitrate + pyridoxine hydrochloride + cyanocobalamin + nicotinamide + calcium pantothenate + riboflavin + vitamin C + folic acid tablet (Sioneuron F), tenofovir disoproxil fumarate + lamividine + efavirenz tablet (AVONZA), diclofenac + methyl salcylate + menthol (Volini Maxx Spray in 55gm pack). Every retailer and dealer shall display price list and the supplementary price list, if any, as furnished by the manufacturer, on a conspicuous part of the premises where he carries on business in a manner so as to be easily accessible to any person wishing to consult the same. Ref: 8

9 PHARMA JOBS Recruitment for Pharmacists (66 posts) in HPSSSB - Government Jobs The eligible candidates can apply online through HP Staff Selection Commission's website hpsssb.hp.gov.in. Applications received through any other mode will not be accepted and will be rejected straightway. Essential qualification(s), eligibility conditions, breakup of posts and examination Fee etc. have been mentioned in the detailed advertisement. Online Recruitment Applications (ORA) can be filled up w.e.f to till p.m. Ref: Job openings for Pharmacists (54 posts) in District Health Society Government Jobs Uttar Pradesh has been working towards strengthening its health systems through various initiatives since the beginning of the National Health Mission (NHM). The State has been making continuous efforts the health objectives set out for it and a multi-pronged strategy has been adopted. Capacity building for professional development of existing doctors in collaboration with leading institutions of the country has been an integral part for strengthening human resources. Post: Pharmacist Programme Name: NUHM Essential Qualification: Intermediate with Diploma In Pharmacy having Registration under UP State Medical Faculty Ref: www. pharmatutors.org Himachal Pradesh Drug Inspector Recruitment Himachal Pradesh HPPSC invites applications from the Pharmacy Degree qualified Professionals for the available Drug Inspector Jobs in HP Health and Family Welfare Department. There are total 13 Drug Inspector jobs in this HPPSC Recruitment Mode of application is online for this HPPSC Drug Inspector Posts recruitment. Last date to apply online for this HP HFWD Drug Inspector jobs is Official website to apply online is Candidates selection is based on screening test or interview only for this Drug Inspector vacancy of HPPSC. Ref: 9

DRUG AND THERAPY BULLETIN PHARMA EXPO PharmaB2B Expo 2018 PHARMAB2B EXPO, organized by WellDone Media is a premier trade show that provides opportunity to connect latest, innovative products and

10 DRUG AND THERAPY BULLETIN PHARMA EXPO PharmaB2B Expo 2018 PHARMAB2B EXPO, organized by WellDone Media is a premier trade show that provides opportunity to connect latest, innovative products and services to pharmaceutical companies. The WellDone Media has already organized five editions of PharmaB2B Expo in different parts of India. Overwhelmed by the positive feedback and demand from the manufacturers, exhibitors and visitors, it is presenting 6th Edition of PharmaB2BExpo in the picturesque and historical place, Vijayawada. Vijayawada is the Southeast Indian, secondmost-populous city of Andhra Pradesh. PharmaB2B Expo at Vijayawada would be organized from July 21-22, 2018 at Sri Sesha Sai Kalyana Vedika. For more information, please visit Indian Pharma Expo & Business Excellence Awards 2018 Indian Pharma Expo & Business Excellence Awards 2018 will be held on August 2018 in New Delhi, India. Indian Pharma Expo (IPE) will provide an opportunity for the participating companies to display their products & services to the gamut of visitors, globally from pharma and healthcare industries. Profile of exhibit based on pharma machinery, ayurvedic / herbal products, allopathic products, nutraceuticals, dietary supplements, cosmetics, veterinary drugs, bio pharmaceuticals, chemicals, API Active pharma ingredients, natural extracts, flavors and fragrances, diagnostic reagents, laboratory equipment and chemicals. 10

11 Which kind of queries can be asked from Drug Information Center? It is the matter of pride for all the population of Himachal Pradesh that there is drug information center (DIC) in the state which is giving the services to promote the rational drug use. Maximum population of state knows that there is DIC, but they are unaware about the services of the DIC. They all are confused that which kind of queries they can ask. There is no any restriction to take the drug query information by any one. Any person (physician, pharmacist, nurse, patient, people of community, old persons, students, researchers etc.) can come in or call in the DIC office to take drug information. Following kinds of queries regarding drugs can be asked from DIC: Ÿ Ÿ Ÿ Ÿ Ÿ Ÿ If patient is administering two medicines at the same time then he/she before administering the medicine, can confirm from DIC that this combination is safe or not safe. If combination will be not safe then it may also be life threatening. If patient is administering a medicine then he/she can confirm which kinds of foods have to be avoided. Someone can confirm that use of any specific medicine in particular condition (like as pregnancy/lactation) is safe or not safe. General information about drug identification can also be taken from the DIC, like as use and side/adverse effects, time of administration, duration of administration, dose in different age groups etc. about any drug. Information about substituted drugs with different prices can also be provided by DIC. Any updation about medicines can be confirmed from DIC. DIC will provide the accurate information on request without any fear and favor. In short, we can say that DIC can provide any kind of information about any medicine to anyone without any cost. Personnel can assess directly, can call in the DIC office, sent the query by post, by 11

Personnel can assess directly, can call in the DIC office, sent the query by post, by E-mail on following address.

12 Personnel can assess directly, can call in the DIC office, sent the query by post, by on following address. Toll Free Note: If any want to publish his/her article in the monthly bulletin of Drug Information Center regarding Pharma updates, they can send their articles with their full address and professional status on the following reference before 25th of every month. DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL Laureate Institute of Pharmacy, Kathog, Jwala Ji, Distt. Kangra HP Website: Mail ID: Toll Free , Phone: , Scan this Quick Response (QR) code to know more You may download any QR code scanner from Play Store/iTunes

NPPA has fixed/revised ceiling prices/retail prices of 22 formulations under Drugs (Prices Control) Order,

What s New 12.06.2018 NPPA has fixed/revised ceiling prices/retail prices of 22 formulations under Drugs (Prices Control) Order, 2013 NPPA has fixed/revised ceiling prices/retail prices of 22 formulations